HypertensionPhase 4NCT00274144
Inflammation and Coronary Artery Disease: Role of AT1-Receptor Antagonism
A Phase 4 study testing telmisartan 40 mg in people with Hypertension and Coronary Arteriosclerosis, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
Effects of AT1 receptor antagonist telmisartan on the primary endpoint inflammatory parameters in patients with coronary artery disease (CAD). Secondary endpoints are alterations in clinical course and blood pressure Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Coronary Arteriosclerosis
- What is being tested?
- telmisartan 40 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2001to May 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated essential hypertension with a mean seated DBP < 95 mm Hg and a mean seated SBP < 160 mm Hg at the randomisation visit (baseline)
- Coronary artery disease confirmed by cardiac catheterization
- > 18 years of age
- Ability to stop current antihypertensive therapy with ACE inhibitors, angioten-sin II receptor antagonist or lipid lowering therapy with statins without risk to the patient in the run-in period of two to four weeks and during the study period.
- Ability to provide written informed consent.
Who cannot join
- Acute coronary syndromes.
- Acute or chronic heart failure (left ventricular ejection fraction < 45 %).
- Symptomatic valvular heart disease.
- Inflammatory diseases (e.g., acute infection, rheumatic diseases, collagenosis).
- Pre-menopausal women (last menstruation < 1 year prior to start of run-in period) who:
- Are not surgically sterile.
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- Are nursing.
- Are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable or injectable contraceptives.
- Known or suspected secondary hypertension.
- Mean sitting SBP > 160 mm Hg or mean sitting DBP > 95 mm Hg during any visit.
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT(ALT) or SGOT(AST) > than 2 times the upper limit of normal range .
- Serum creatinine > 2.3 mg/dL.
- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one kidney.
- Clinically relevant hypokalaemia or hyperkalaemia.
- Uncorrected volume depletion.
- Uncorrected sodium depletion.
- Primary aldosteronism.
- Hereditary fructose intolerance.
- Biliary obstructive disorders.
- Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
- History of drug or alcohol dependency within 6 months.
- Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol (cf. 4.2.1).
- Current participation in another trial, or participation in a trial within a period of one month.
- Known hypersensitivity to any component of the formulation.
- Has no contra-indication to a placebo run-in period (e.g., recent stroke or MI).
- Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: Inflammation and Coronary Artery Disease. Role of AT1 Receptor Antagonism
Effects of AT1 receptor antagonist telmisartan on the primary endpoint inflammatory parameters in patients with coronary artery disease (CAD). Secondary endpoints are alterations in clinical course and blood pressure
Read the detailed description
Methodology:
Randomised, double-blind and placebo-controlled parallel group design
Planned/actual number of subjects:
Enrolled: 40/50 randomised: 40/42 completed: 40/42
Diagnosis and main criteria for inclusion:
Treated essential hypertension with a mean seated DBP/SBP smaller than 95 mmHg/160 mmHg, coronary artery disease confirmed by catheterization and age equal or greater than 18 years of age.
Duration of treatment:
12 weeks: telmisartan 40 mg or placebo 40 mg
Study Hypothesis:
The statistical null hypothesis is that in patients with CAD and mild-to-moderate hypertension, a 84-day therapy with 40 mg telmisartan causes changes in inflammatory and leukocyte adhesion parameters. The alternative hypothesis is that this therapy does not influence inflammatory and leukocyte adhesion parameters. This hypothesis is tested by the nonparametric Wilcoxon test for unpaired samples.
Comparison(s):
Placebo 40 mg
- Conditions
- Hypertension, Coronary Arteriosclerosis
- Being tested
- telmisartan 40 mg, placebo 40 mg
- Medical subject headings
- Hypertension, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartan 40 mgDrug
placebo 40 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in the inflammatory parameters: hsCRP, IL-6, IL-10, sICAM-1, TNF-alpha, MCP-1, LFA, MAC-1, L- selectin, FcyRIII and PECAM-1
Secondary outcomes (1)
Alterations of clinical parameters such as clinical outcome, and changes in blood pressure. Safety and tolerability in terms of incidence and severity of adverse events, changes in physical examination, heart rate, laboratory parameters, and 12-lead-ECG.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startDec 2001
- Primary completionMar 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Pharma GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274144
- Sponsor's protocol ID
- 502.385
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2006
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Inflammation and Coronary Artery Disease. Role of AT1 Receptor Antagonism
- ClinicalTrials.gov ID
- NCT00274144
- Acronym / sponsor ID
- 502.385
- Conditions
- Hypertension, Coronary Arteriosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Primary completion
- Mar 2004 (actual)
- Study completion
- May 2004
- First posted
- 10 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effects of AT1 receptor antagonist telmisartan on the primary endpoint inflammatory parameters in patients with coronary artery disease (CAD). Secondary endpoints are alterations in clinical course and blood pressure
Detailed description
Methodology:
Randomised, double-blind and placebo-controlled parallel group design
Planned/actual number of subjects:
Enrolled: 40/50 randomised: 40/42 completed: 40/42
Diagnosis and main criteria for inclusion:
Treated essential hypertension with a mean seated DBP/SBP smaller than 95 mmHg/160 mmHg, coronary artery disease confirmed by catheterization and age equal or greater than 18 years of age.
Duration of treatment:
12 weeks: telmisartan 40 mg or placebo 40 mg
Study Hypothesis:
The statistical null hypothesis is that in patients with CAD and mild-to-moderate hypertension, a 84-day therapy with 40 mg telmisartan causes changes in inflammatory and leukocyte adhesion parameters. The alternative hypothesis is that this therapy does not influence inflammatory and leukocyte adhesion parameters. This hypothesis is tested by the nonparametric Wilcoxon test for unpaired samples.
Comparison(s):
Placebo 40 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Treated essential hypertension with a mean seated DBP < 95 mm Hg and a mean seated SBP < 160 mm Hg at the randomisation visit (baseline)
- Coronary artery disease confirmed by cardiac catheterization
- > 18 years of age
- Ability to stop current antihypertensive therapy with ACE inhibitors, angioten-sin II receptor antagonist or lipid lowering therapy with statins without risk to the patient in the run-in period of two to four weeks and during the study period.
- Ability to provide written informed consent.
Key exclusion criteria (27 listed)
- Acute coronary syndromes.
- Acute or chronic heart failure (left ventricular ejection fraction < 45 %).
- Symptomatic valvular heart disease.
- Inflammatory diseases (e.g., acute infection, rheumatic diseases, collagenosis).
- Pre-menopausal women (last menstruation < 1 year prior to start of run-in period) who:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telmisartan 40 mg | Drug | – |
| placebo 40 mg | Drug | – |
Primary outcome
Alterations in the inflammatory parameters: hsCRP, IL-6, IL-10, sICAM-1, TNF-alpha, MCP-1, LFA, MAC-1, L- selectin, FcyRIII and PECAM-1
1 secondary outcome
Alterations of clinical parameters such as clinical outcome, and changes in blood pressure. Safety and tolerability in terms of incidence and severity of adverse events, changes in physical examination, heart rate, laboratory parameters, and 12-lead-ECG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
B.I. Pharma GmbH & Co. KG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing telmisartan 40 mg in people with Hypertension and Coronary Arteriosclerosis, run by Boehringer Ingelheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in the inflammatory parameters: hsCRP, IL-6, IL-10, sICAM-1, TNF-alpha, MCP-1, LFA, MAC-1, L- selectin, FcyRIII and PECAM-1. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.